# K121607: Terumo (R) Needle

- Pathway: 510(k) (Traditional)
- Applicant: Terumo (Philippines) Corporation
- Decided: Nov 8, 2012 after 160 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771203 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001572: Neolus Needle, Terumo Europe N.V. (2000) Summary page 4.
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 3.
- K012646: Terumo 30 Gauge Hypodermic Needle, Terumo Medical Corp. (2001) Summary page 3.

## Recalls of this device
- Feb 8, 2019 · Class II · Z-1998-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2006-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2002-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2001-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2004-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-1999-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2003-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2000-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.
- Feb 8, 2019 · Class II · Z-2005-2019: There is a potential for a loss of package integrity that may compromise the sterility of the product.

## Indications for use
The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K121607
Methodology: https://510kreport.com/methodology